A Randomized, Double-Blind, Placebo Controlled Study of l-Leucovorin in Combination With Trimethoprim / Sulfamethoxazole in the Therapy of Pneumocystis Carinii Pneumonia in Patients With the Acquired Immunodeficiency Syndrome
NCT ID: NCT00002002
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Trimethoprim
Sulfamethoxazole
Leucovorin calcium
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of PCP.
* Fit the CDC definition of AIDS.
* Be receiving intravenous or oral trimethoprim / sulfamethoxazole (Bactrim, Septra) in doses of = or \> 15mg/kg/day of the trimethoprim component.
* Be receiving = or \< 48 hours of trimethoprim / sulfamethoxazole (TMP / SMX) prior to randomization.
* Must sign informed consent in accordance with FDA guidelines.
Exclusion Criteria
Patients with the following conditions or symptoms are excluded:
* Cannot take oral medications.
* Require continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone.
Concurrent Medication:
Excluded:
* Continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone.
Patients with the following are excluded:
* Cannot take oral medications.
* Require continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone.
Prior Medication:
Excluded:
* \> 48 hours of trimethoprim / sulfamethoxazole prior to randomization.
18 Years
ALL
No
Sponsors
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Lederle Laboratories
INDUSTRY
Locations
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San Francisco Gen Hosp
San Francisco, California, United States
Countries
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References
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Safrin S, Lee BL, Sande MA. Adjunctive folinic acid with trimethoprim-sulfamethoxazole for Pneumocystis carinii pneumonia in AIDS patients is associated with an increased risk of therapeutic failure and death. J Infect Dis. 1994 Oct;170(4):912-7. doi: 10.1093/infdis/170.4.912.
Other Identifiers
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76-9
Identifier Type: -
Identifier Source: secondary_id
056A
Identifier Type: -
Identifier Source: org_study_id